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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database
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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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Fusion, AEs, Surg Procedures


 
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General
Study Status Terminated
522 Number / Requirement Number PS090011 / PSS001
Date Original Plan Accepted 04/29/2011
Date Current Plan Accepted 04/12/2012
Study Name Fusion, AEs, Surg Procedures
Device Name Dss stabilization system
Root Document Number K072969 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives "The design is a prospective multicenter, single-armcohort study with a literature control.
A formal statement of the primary study null and alternative hypotheses is:

Ho: pi-DSS-pi-c<-delta
Ha:pi-DSS-pi-c> -delta

where pi-DSS is the two-year cumulative fusion rate among patients implanted with DSS-TM;TT-c is the fixed (historical control) target; and delta is the selected non-inferiority delta. A non-inferiority margin delta =-0.10 is conventional in similar contexts and was chosen as the value for this study. The literature search resulted in a 75.4% fusion rate for control pedicle screw spinal systems using autograft."
Study Population Skelletally mature patients who received DSS System at T4 to S1 vertabrae as an adjunct to fusion for the cleared device indications.
Sample Size 150 patients, 6 sites
Key Study Endpoints Fusion, adverse events, surgical procedures
Follow-up Visits and Length of Follow-up Follow-up visits at 6 wks., 6 mos., 12 mos., and 24 mos. Length of follow-up --- 2 years


Fusion, AEs, Surg Procedures Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/28/2011 02/03/2012 Overdue/Received
1 year report 04/28/2012 06/21/2012 Overdue/Received
18 month report 10/27/2012 10/22/2012 On Time
2 yr report 04/27/2013 04/29/2013 Overdue/Received
30 month report 10/27/2013 10/31/2013 Overdue/Received
3 yr report 04/27/2014 04/30/2014 Overdue/Received
4 yr report 04/28/2015 04/30/2015 Overdue/Received


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources
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